Blood-brain barrier permeability in cerebral small vessel disease: a dynamic contrast-enhanced MRI study.

Completed

• Conditions: Cerebral small vessel disease; disease of the small brain arteries; 10007963; 10009841

• Registration Number: NL-OMON41443
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

LACI patients: A first-ever acute lacunar stroke ;Mild VCI due to cSVD:
- Subjective complaints of cognitive functioning and objective cognitive impairment in at least 1 cognitive domain on cognitive testing, and
- A Clinical Dementia Rating <=1 and a MMSE >=20 (i.e. no dementia), and
- Vascular lesions on brain MRI (lacunar infarts, white matter lesions, deep microbleeds) that suggest a link between the cognitive deficit and cSVD.;Healthy control subjects: Healthy control subjects are included from the general population and matched to the LACI and mild VCI patients according to gender and age.

Exclusion Criteria

Exclusion criteria for all subjects:
Cerebrovascular abnormalities in history
o Ischemic stroke
o Haemorrhagic stroke (subarachnoid or intracerebral)
Contra indications for MRI/DCE-MRI
o Heart valve prosthesis
o Pacemaker
o Intracerebral clips (aneurysm)
o Intra-ocular metal pieces
o Cochlear implant
o Claustrophobia
o Poor kidney function (GFR<30ml/min)
o Previous allergic reaction to contrast agent (gadobutrol)
Psychiatric disorders associated with (temporarily) cognitive decline (e.g. depression, psychosis);Group specific exclusion criteria:
Lacunar stroke
- Potential cardiac embolic source (e.g. atrial fibrillation)
- Stenosis of >=50% of one or both internal carotid arteries.
Mild cognitive impairment due to cSVD
- Clinical and/or subclinical cortical events
- Other causes for cognitive impairment (e.g. Alzheimers Disease)
Healthy subjects
- Clinically overt cardiovascular diseases
- Clinically overt cerebrovascular diseases
- Disease of the central nervous system (e.g. Multiple Sclerosis, brain tumor/metastasis)
- Extensive structural lesions on MRI associated with cSVD
- Cognitive impairment (i.e. objective and/or subjective cognitive deficits).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>BBB permeability, cognitive function, extent of structural lesions on MRI<br /><br>associated with cSVD (WML, lacunar infarcts, BMB).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Sublingual glycocalyx thickness</p><br>